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A Pragmatic Pilot Randomized Controlled Trial of the OA Go Away Among Individuals with Osteoarthritis of the Hip or Knee.

ABSTRACT: Purpose: The main objective was to assess the feasibility of conducting a full randomized controlled trial (RCT) to test the effectiveness of the OA Go Away (OGA) behavioural intervention on adherence to prescribed exercise, level of physical activity, goal attainment, and health outcomes, and to determine the acceptability of the OGA. The OGA is an internal reinforcement tool designed to promote exercise adherence for people with hip or knee OA. Method: This 3-month pragmatic pilot RCT included 40 participants with hip or knee OA who were randomized into the treatment group who used the OGA for three months, or standard care. Results: This pilot RCT which included 37 participants (17 in the treatment group and 20 in the control group) showed that it would be feasible to complete a full RCT of the OGA behavioural intervention with adjustments to the format of the OGA (electronic), inclusion criteria, outcome measures and duration. The OGA was felt to be useful (75%) and motivational (82%) by participants. Conclusions: This pilot RCT justifies a formal RCT of the OGA and shows promising results concerning its acceptability, especially if available in an electronic format.

SUBMITTER: Paterson G

PROVIDER: S-EPMC10262722 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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A Pragmatic Pilot Randomized Controlled Trial of the OA Go Away Among Individuals with Osteoarthritis of the Hip or Knee.

Paterson Gail G Gaboury Isabelle I Bernick Jordan J Wells George A GA Tugwell Peter P Toupin-April Karine K

Physiotherapy Canada. Physiotherapie Canada 20220824 4

Purpose: The main objective was to assess the feasibility of conducting a full randomized controlled trial (RCT) to test the effectiveness of the OA Go Away (OGA) behavioural intervention on adherence to prescribed exercise, level of physical activity, goal attainment, and health outcomes, and to determine the acceptability of the OGA. The OGA is an internal reinforcement tool designed to promote exercise adherence for people with hip or knee OA. Method: This 3-month ...[more]

PMID: 37324606

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Project description:BACKGROUND:As guidelines and payers increasingly recommend use of patient decision aids (DAs), evidence about the comparative effectiveness of available DAs is critical for organizations interested in implementing them. The primary purpose of this study was to compare 2 DAs with regard to their ability to help patients become informed and receive their preferred treatment (that is, make an informed patient-centered decision), shared decision-making, surgical rates, and surgeon satisfaction. METHODS:We performed a multisite factorial randomized trial enrolling patients with hip or knee osteoarthritis. Patients were randomly assigned to use a long, detailed DA (long DA) or short, interactive DA (short DA). Eight surgeons were randomly assigned to receive a patient preference report detailing the patient's goals and treatment preferences or to administer usual care. RESULTS:We distributed 1,636 pre-visit surveys, 1,220 of which were returned (75% response rate), and 1,124 post-visit surveys, 967 of which were returned (86% response rate). The patients in the sample had a mean age (and standard deviation) of 65 ± 10 years, 57% were female, 89% were white non-Hispanic, and 67% had knee osteoarthritis. The majority (67.2%) made informed patient-centered decisions, and the rate did not vary significantly between the DA groups (p = 0.97) or between the surgeon groups (p = 0.23). Knowledge scores were higher for the short-DA group (mean difference = 9%; p < 0.001). More than half of the sample (60.5%) had surgery within 6 months after the visit, and rates did not differ significantly by DA or surgeon group. Overall, the surgeons were highly satisfied and reported that the majority (88.7%) of the visits were of normal duration or shorter. CONCLUSIONS:The DECIDE-OA study is, to our knowledge, the first randomized comparative effectiveness study of 2 orthopaedic DAs. The short DA outperformed the long DA with regard to knowledge scores and was comparable with respect to other outcomes. The surgeons reported high satisfaction and normal visit duration with both DAs. CLINICAL RELEVANCE:Surgeons need to ensure that patients with osteoarthritis are well-informed and have a clear preference regarding whether to undergo hip or knee replacement surgery. The DAs used in this study may help surgeons involve patients in elective surgery decisions and meet the requirements of informed consent.

Project description:BackgroundSynovitis occurring frequently in osteoarthritis (OA) may be a targeted outcome. There are no data examining whether synovitis changes following intra-articular intervention.MethodsPersons aged 40 years and older with painful knee OA participated in an open label trial of intra-articular steroid therapy. At all time points they completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. They had a contrast-enhanced (CE) MRI immediately prior to an intra-articular steroid injection with a repeat scan within 20 days. Response status was assessed using the Osteoarthritis Research Society International (OARSI) response criteria. OARSI responders were followed until their pain relapsed either within 20% of baseline or 6 months, shortly after which a third MRI was performed. Synovial tissue volume (STV) was measured on postcontrast knee images. We looked at changes in the STV and in pain, and their association.Results120 subjects with preinjection and postinjection CE MRI were followed. Their mean age was 62.3 years (SD=10.3) and 62 (52%) were women. The median time between injection and follow-up scan was 8 days (IQR 7-14 days). 85/120 (71%) were OARSI responders. Pain decreased (mean change in KOOS=+23.9; 95% CI 20.1 to 27.8, p<0.001) following steroid injection, as did mean STV (mean change=-1071 mm(3); 95% CI -1839 mm(3) to -303 mm(3), p=0.01). Of the 80 who returned for a third MRI, pain relapsed in 57, and in the 48 of those with MRI data, STV increased between follow-up and final visit (+1220 mm(3); 95% CI 25 mm(3) to 2414 mm(3), p=0.05). 23 were persistent responders at 6 months and, in these, STV did not increase (mean change=-202 mm(3); 95% CI -2008 mm(3) to 1604 mm(3), p=0.83). Controlling for variation over time, there was a significant association between synovitis volume and KOOS pain (b coefficient-change in KOOS pain score per 1000 mm(3) change in STV=-1.13; 95% CI -1.87 to -0.39, p=0.003), although STV accounted for only a small proportion of the variance in change in pain.ConclusionsSynovial tissue volume in knee OA shrinks following steroid therapy, and rebounds in those whose pain relapses. It can be considered a treatment target in symptomatic knee OA.Trial registration numberISRCTN07329370.

Project description:Aim:The aim of the present study was to evaluate the effect of E-OA-07 on individuals having osteoarthritis of the knee. Background:Lanconone® (E-OA-07) is a widely marketed dietary supplement which has been previously studied in different clinical settings for managing chronic joint pain. This was a confirmatory study planned at a lowered dose regimen with the purpose of improving compliance and reducing consumer cost. Methods:Male and female participants aged between 40 and 65 years, with history of joint pain for at least 3 years, were recruited. Knee joint dysfunction of grade II/III was radiographically characterized as per Kellgren-Lawrence system of classification. Enrolled participants were randomized to receive E-OA-07 at a dose of 1000 mg/day or placebo over a period of 8 weeks. The primary efficacy parameter was assessment of change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Whereas, the secondary parameters explored in the study included WOMAC subscales of stiffness and physical function, EQ-5D-5L questionnaire, systemic inflammatory marker (hs-CRP) and self-assessment of treatment satisfaction. Results:At the end of 8 weeks, joint pain severity as per WOMAC was found to be significantly reduced in the E-OA-07 group as compared to placebo (p<0.001). Similar improvement was observed in the subscales of stiffness and physical function which corresponds to significant improvement in the quality-of-life standards of E-OA-07 participants (p<0.001), reporting higher treatment satisfaction (p<0.001). Conclusion:E-OA-07 at a dose of 1000 mg/day was able to significantly reduce joint pain and thereby improve joint mobility in study participants. At the end of the study period, there was a clinically relevant change of 45.55%, 45.91% and 38.19% for pain, stiffness and physical function, respectively. Moving forward, studies could be planned for understanding the cartilage regenerative properties of E-OA-07.

Project description:IntroductionHip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care.MethodsThis study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation.DiscussionAfter a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants' behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs.Trial registrationGerman Clinical Trials Register, DRKS00028477. Registered on August 10, 2022.

Project description:ObjectiveTo evaluate the cost-utility and cost-effectiveness of the dr. Bart app compared to usual care in people with osteoarthritis (OA) of the knees and hips, applying a health care payer perspective.MethodsThis economic evaluation was conducted alongside a 6-month randomized controlled trial that included 427 participants. The dr. Bart app is a stand-alone eHealth application that invites users to select pre-formulated goals (i.e., "tiny habits") and triggers for a healthier lifestyle. Self-reported outcome measures were health care costs, quality-adjusted life years (QALYs) according to the EuroQol 5-dimension 3-level (EQ-5D-3L) descriptive system, the EuroQol visual analog scale (QALY VAS), patient activation measure 13 (PAM-13), and 5 subscales of the Knee Injury and Osteoarthritis Outcome Score/Hip Disability and Osteoarthritis Outcome Score. Missing data were multiply imputed, and bootstrapping was used to estimate statistical uncertainty.ResultsThe mean ± SD age of the study participants was 62.1 ± 7.3 years, and the majority of participants were female (72%). Health care costs were lower in the intervention group compared to the group who received usual care (€-22 [95% confidence interval €-36, -3]). For QALY and QALY VAS, the probability of the dr. Bart app being cost-effective compared to usual care was 0.71 and 0.67, respectively, at a willingness-to-pay (WTP) of €10,000 and 0.64 and 0.56, respectively, at a WTP of €80.000. For self-management behavior, symptoms, pain, and activities of daily living, the probability that the dr. Bart app was cost-effective was >0.82, and the probability that the dr. Bart app was cost-effective in the areas of activities and quality of life was <0.40, regardless of WTP thresholds.ConclusionThis economic evaluation showed that costs were lower for the dr. Bart app group compared to the group who received usual care. Given the noninvasive nature of the intervention and the moderate probability of it being cost-effective for the majority of outcomes, the dr. Bart app has the potential to serve as a tool to provide education and goal setting in OA and its treatment options.

Dataset Information

A Pragmatic Pilot Randomized Controlled Trial of the OA Go Away Among Individuals with Osteoarthritis of the Hip or Knee.

Publications

A Pragmatic Pilot Randomized Controlled Trial of the OA Go Away Among Individuals with Osteoarthritis of the Hip or Knee.

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